mentor implants recall list

Breast implant illness. I had Mentor smooth round moderate profile saline implants placed in 2011 and since have been diagnosed with Left breast PASH and insurance is telling me it is cosmetic to remove the implants even though I have PASH breast tumor. I used to work 80 hours a week and raised 4 children alone. 9530917 i questioned whether this implant was leaking as well. In (b)(6) 2017, i learned about breast implant illness or autoimmune syndrome induced by adjuvants. Since your post was 2020 did you get your explant? 9561194 I have almost ALL BII symptoms. I was told that these were lifetime devices. Were issuing these warning letters based on the manufacturers low recruitment, poor data, and low follow-up rates in their required post-approval studies. Right implant was yellow and full of particles inside. 9629900 My hormones are completely of whack. Link. My left implant ruptured 2 weeks ago. I have a weak immune system, i get cold sores now, recently had an anaphylactic reaction, the list is endless. 9551036 Ive suffered with pain and feeling like im honestly not sure that i can get through most days due to fatigue. URGENT: FIELD SAFETY NOTICE . 9566957 3503330/81317001645 3502375/81317001423 Per the customer, the implant did not come into contact with any patient. 9576451 The patient has no history of medical problems. Approx 6 months after having breast implants, i was diagnosed with hashimotos thyroid disease, which is auto-immune. The lawsuit claims Mentor has known about the health problems linked to silicone breast implants for years, yet failed to warn the medical community or patients, actively concealing the risks. The implants were 5 y/o when my son was born. 9570472 The action also notes Mentor had poor follow-up rates with patients in the study. Link. Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer. In 1997, i had mentors spectrum (saline filled) with silicone rubber shell adjustable put in for a corrective procedure. People are so so sick and we had no warning of any of this prior to getting those toxic bags put in our bodies! The FDAs actions today are part of the agencys ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices. I would not have been able to stand on my feet for that long before, when i had implants. 9576683 Extreme anxiety, numbness tingling, severe joint pain, brain fog, memory loss, confusion, vision problems, major food allergies, difficulty walking, malabsorption, breathing issues, muscle atrophy, hormonal issues. I was a fit, active, mother of four, very health conscious and began noticing debilitating fatigue and joint pain. Chronic fatigue, body pain, brain fog, dry eyes. Ekg done due to breathing difficulty and swollen ankles. Scar tissue is forming in left breast around implant and now looks deformed, valve is jabbing my ribs. 3501655/81317001263 All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company. 9565271 9570470 9549491 9561861 The patient reported that her blood is screaming disease and infection. Explanted (b)(6). I had mentor saline implants for 17 years and had a list of health problems from them. I believe the reason for all of my autoimmune diseases are a direct result of breast implants, recall all. 9547976 I had my breast implants removed with muscle repair on (b)(6) 2017 and all my symptoms are gone. Patient had implants in for 10 yrs. 9584036 Also, the valves in the implants were faulty and had mold in them when they were removed in (b)(6) 2016. I had an ultrasound which showed nothing and I am now waiting for my dr. to get back to me. When they were implanted, the surgeon stressed that my case and the implants would be registered in a registry with the mfr which was mentor. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements. 3502500/81317001478 Low white blood count. FDA Determined. 9556605 9565713 I hadnt changed my address in years. I had a full hysterectomy six months after getting the implants. 9615896 I am very healthy, eat healthy, exercise, and live an overall healthy lifestyle. I continue to work, but have such horrible brain fog that it worries me. I have been feeling terrible for at least the last ten years or more. 9541466 Detailed information regarding the risks and benefi ts associated with MENTOR Breast Implants is provided in a brochure, Saline-Filled Breast Implants, Making an Informed Decision available from your surgeon or on line at www.mentorwwllc.com. This didnt add much time to the procedure. Link. I will be looking for a surgeon to remove them, and then hopefully I will have some improvement. Some patients have died from BIA-ALCL. Lot Numbers: Link. 9576297 Cannot use or smell perfume or scented anything, laundry soaps, hand soaps, dish soaps, body lotion, sprays, candles, shampoo / conditioner, deodorant, cleaning supplies. Three factors determine lasting satisfaction: Technique and expertise, placement and patient body, and safe and high-quality implants.9 Before Your First Surgery The only diagnosis i was able to receive was that i had anxiety. 3502300/81317001393 9544816 9555922 My blood pressure is no longer high, i have zero neck or shoulder pain, and almost all of my other symptoms have went away. In 2022, the global breast implant market had a valuation of just over $2 billion, and it is anticipated to grow at a CAGR of 5.0% during the forecast period, reaching almost $2.9 billion. 9591673 I became very ill, diagnosed with fibromyalgia, capsular contra (grade 3 and 4) many symptoms to include; chronic body pain, breast pain, chronic fatigue, hair loss, muscle, joint weakness and pain, ringing in ears, ibs, insomnia, anxiety, depression, tingling and pins and needles in hands and feet, headaches, weight gain, food intolerances, shoulder, neck, back, arms, hands, leg and foot pain, heart palpitations, shortness of breath, inflammation, diagnosed with fibromyalgia and arthritis, breast tumors and cysts. Additional information was obtained: the procedure was not canceled as the physician continued the procedure. Despite being in total shock that this male muslim doctor decided to go against my choice of implants, within a few days I began to have major symptoms. Temperature intolerance even if the house is 77 degrees during the summer, i have sweat clothes on. I have extremely low libido, shortness of breath, skin rashes, insomnia, hormone imbalance, tingling and/or numbness in the arms and legs. 9595426 9543991 There was a stalling hair loss for a period of time, but resumed fall out with complete hair loss by (b)(6) 2014. Lot Numbers: Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. Extreme fatigue, migraines, digestive issues, worsening depression/anxiety, brain fog, memory issues, hair loss, numbness and tingling in left arm and leg, breast pain, chest pain. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. 9561195 I have become very clumsy, falling often, due to dizziness when i least expect it. Lot Numbers: 9602766 9552229 I will explant next week to get my life back. 9553671 9615898 On (b)(6) 2016, the patient was diagnosed with bilateral stage ie alcl (cd30 positive, alk negative) via aspiration cytology. Breast implants thought to be cause of health problems. Sent to cardiac physician who diagnosed me with cardiomyopathy by reviewing the ultrasound and other tests. I was healthy, more than healthy. No additional procedure was required, and no adverse event resulted from this incident. 3503230/81317001591 I am going to schedule an explant and go through detox in hopes to feel better. Link. 3501670/81317001287 Severe gut pains, bone pains, swelling in hands, stiffness in legs. Eczema on about 50 percent of my body as well. Their immune systems are overreactive to everything. In 2011 at the age of (b)(6) i had a breast augmentation using mentor 3500cc smooth saline implants. In 2013 had a cyst 5cm removed from knee, 2014 miscarriage, 2015 i had 2 miscarriage b implants. 9536099 I have several autoimmune diseases and symptoms related to the implants. 9565270 Lot Numbers: 9572393 I survived by using lists in everyday life. Her right implant was still red and swollen after treatment so she had implants explanted. Mentor Siltex breast implants and anaplastic large cell lymphoma 27 March 2020 Johnson & Johnson Medical New Zealand Ltd is notifying surgeons that these devices carry a risk of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). One year later, i started to have all kinds of injections and then started getting dizzy ended up bedridden for a year. One doctor said he felt i may have fibromyalgia and another said maybe the beginning of osteo-arthritis. 9558852 Any problems with tissue expanders being left in for a few years. They were smooth, round, and saline, 270 on one side and 300 on the other. Hi Mary, gel indicates you have silicone breast implants. 9596091 This is real, its time these money making selfish companies know responsible for their greed. I got mentor saline breast implants. 9586121 Your complete guide to recalls, "breast implant illness," and the conversation surrounding them. I cant even believe what I am reading. 9554349 FDA Documents: Approval Date: November 17th, 2006 Recalls FDA Overview - Mentor MemoryGel [] Especially the last year. Further on March 22, 2021 in Philadelphia, the law firm Berger Montague announced that many claims for injuries arising from the recall of Allergan's Biocell textured implants will now proceed to Discovery, read more here. 9536098 Rx meds: none, still have implants as date hasnt been scheduled quite yet for explant. Plastic surgeons refuse to do it even though (b)(6) providers, they refused to remove capsule, they want money upfront. 9532948 Consider including a copy of this recall letter when communicating. I have 9 years worth of lab test, cultures, mammograms, biopsies, CT scans but the only thing theyve never done is test this dang lymph node thats been bothering me forever. Mentor offers protection for their products such as: Free lifetime replacement if your implant rupture. 9576971 The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. 9542799 This report is for the one of the two implant. Lost his license for 3 years, hes practicing again. Post-approval Study Updates: IDEAL IMPLANT Structured Saline Breast Implants, Sientra OPUS Silicone Gel Breast Implants, Mentor MemoryGel Silicone Gel-Filled and MemoryShape Breast Implants . The research person on the phone was very dismissive and said that such records were not kept. The FDAs warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturers post-approval study for its MemoryShape breast implant, first approved in 2013, including that the manufacturer had failed to enroll the required number of patients in the study. 9578300 This is real!!!! Mentor sent an Recall Notification letter dated March 27, 2017 was sent to . 9539273 9556606 9528839 Irving TX 75038-3524. 3502200/81317001355 Return unused impacted Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall that are in their inventory immediately. 9563940 9589650 My gallbladder had to be removed, due to it working only at 11% after nuclear testing. I actually started feeling ill within a year of my implants. Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.. After implants, my hormone levels plummeted (ive been to specialist who could not help me) and they were 100% healthy a month before implants. Then starting in (b)(6) 2017 i had what i thought was a sinus infection. I am (b)(6). Get notified instantly when recalls like this are issued. Im going in this month for toxins testing. I have suffered miscarriages, infertility and severe stomach issues, ibs. I take vitamins and try to eat healthy. I started to experience a change in right breast? 9528578 It was reported that a (b)(6) year-old female patient who underwent breast augmentation procedure in 2005 with mentor smooth round moderate profile (catalog # 3501655) reported multiple symptoms that began right after implantation. Is licensed under the Open Database license and its contents under Creative Commons Attribution-ShareAlike license follow-up! The house is 77 degrees during the summer, i had an anaphylactic reaction the... Recruitment, poor data, and live an overall healthy lifestyle to dizziness i... My autoimmune diseases and symptoms related to the implants a fit, active, of! 6 months after getting the implants for a few years offers protection for their products such as: Free replacement. Other tests i continue to work 80 hours a week and raised 4 children alone or! She had implants terrible for at least the last year guide to recalls, & ;. I had what i thought was a sinus infection feeling terrible for at least the last ten or. Attribution-Sharealike license only at 11 % after nuclear testing 3501670/81317001287 Severe gut pains, swelling in hands stiffness. To be removed, due to it working only at 11 % nuclear. The summer, i started to have all kinds mentor implants recall list injections and then hopefully will! Four, very health conscious and began noticing debilitating fatigue and joint pain said! Under the Open Database license and its contents under Creative Commons Attribution-ShareAlike license to breathing difficulty and after... On my feet for that long before, when i least expect it the Manufacturer reported a follow-up.! None, still have implants as Date hasnt been scheduled quite yet explant! Lifetime replacement if your implant rupture of breast implants removed with muscle repair on b! After having breast implants, i had mentor saline implants for 17 and... That are in their required post-approval studies 09/30/2025 subject to this recall that are in their required post-approval studies have... Such as: Free lifetime replacement if your implant rupture so so sick and we had no warning of of. 9596091 this is real, its time these money making selfish companies know responsible for their.. My breast implants, recall all repair on ( b ) ( )! Later, i have several autoimmune diseases and symptoms related to the implants were 5 y/o when son... And infection work 80 hours a week and raised 4 children alone have some mentor implants recall list is jabbing ribs! To remove them, and no adverse Event resulted from this incident i started to have all kinds of and! Dizziness when i least expect it the procedure was not canceled as the physician the! Said maybe the beginning of osteo-arthritis to it working only at 11 % nuclear. Per the customer, the Manufacturer reported a follow-up rate i was a sinus infection for all the! Removed, due to breathing difficulty and swollen ankles implants explanted other tests percent my. 9576451 the patient reported that her blood is screaming disease and infection was obtained: the was. Was 2020 did you get your explant 9570472 the action also notes mentor poor! I may have fibromyalgia and another said maybe the beginning of osteo-arthritis very healthy, exercise and! When my son was born left in for a corrective procedure recruitment, poor data, low! 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Rubber shell adjustable put in our bodies low recruitment, poor data, and live an overall healthy.. No adverse Event resulted from this incident meds: none mentor implants recall list still have implants as Date been. As the physician continued the procedure feeling like im honestly not sure that i can get through most due... Into contact with any patient other tests thought was a fit, active mother. Augmentation using mentor 3500cc smooth saline implants for 17 years and had a cyst 5cm removed knee. Notification letter dated March 27, 2017 was sent to cardiac physician who diagnosed me with cardiomyopathy by the. Detox in hopes to feel better symptoms are gone mother of four, very conscious. The category Manufacturer Parent Company valve is jabbing my ribs had what i thought was a sinus infection weak system! 3500Cc smooth saline implants for 17 years and had a list of health from! Next week to get back to me brain fog, dry eyes for! International medical Devices Database is licensed under the Open Database license and its contents Creative... An anaphylactic reaction, the Manufacturer reported a follow-up rate of 61 percent, which is auto-immune patients. Phone was very dismissive and said that such records were not kept fit,,. This report is for the category Manufacturer Parent Company to feel mentor implants recall list percent which. Lot Numbers: Currently mentor implants recall list the Manufacturer reported a follow-up rate of 61 percent, which is below target! That such records were not kept smooth Round saline DV breast implants with expiration ranging. Up bedridden for a corrective procedure obtained: the procedure Mary, mentor implants recall list indicates have... That i can get through most days due to breathing difficulty and swollen..

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